Advanced Viral Research granted patent for treatment of human infections.

Advanced Viral Research Corporation (Yonkers, NY) has been awarded United States Patent 6,670,118 entitled "Method for Treating Papillomavirus Infections". The patent describes the use of AVR118 (previously known as Product R) for the topical treatment of patients suffering with lesions resulting from human papillomavirus (HPV) infections, including genital warts.

ADVR has completed a Phase I clinical trial in the United States to evaluate the safety of topical application of AVR118 in healthy volunteers. There were no local adverse reactions to the application of AVR118 to the skin of these subjects. The company is now planning Phase II trials for the topical use of AVR118.

HPV is a common world-wide sexually transmitted infection (STI). The American Social Health Association estimates there are approximately 5.5 million new cases of sexually transmitted HPV infections reported each year and at least 20 million Americans are infected.

The most common clinical manifestation of HPV is warts which are benign tumors. The most common infections caused by strains of HPV are digital and plantar warts -- warts on the hands and feet, commonly seen in children. These warts represent one of the most prevalent dermatologic infections worldwide. Several strains of HPV are associated with the appearance of cervical cancer which is one of the most common malignancies infecting women. Some 500,000 cases of invasive cervical cancer are diagnosed worldwide each year. In developing nations, cervical cancer is the most common female malignancy, accounting for 24% of all cancers in women. In developed countries, cervical cancer ranks behind cancer of the breast, lung, uterus and ovaries, accounting for some 7% of all cancers in women.

Patients suffering with immunodeficiencies, such as patients with AIDS, are particularly susceptible to infection with HPV. Disseminated HPV in.fection is one of the opportunistic infections complicating AIDS and is manifested by eruption of generalized, often very painful warts over the body. At present, there is no specific and satisfactory therapy for disseminated HPV infection in AIDS patients.

"Use of AVR118 in the treatment of HPV infection is a potentially significant contribution of AVR118 to the therapy of a prevalent and troublesome viral infection that is responsible for much morbidity over the world. The potential of AVR118 as a therapy for disseminated HPV infection in patients with AIDS merits further clinical study," said James T. D'Olimpio M.D., a clinical consultant to ADVR.

ADVR's AVR118 represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.

Advanced Viral Research Corp.

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